| CLINICAL STUDY |
Targeting complications of scleroderma Scleroderma is an autoimmune disease characterized by an increase in connective tissue in skin and internal organs that accompanies vascular inflammation and vessel obliteration. Endothelin is implicated in this process. Digital ulcers (DUs) are a common complication of scleroderma, affecting some 25% of patients (approximately 5,000 severe cases worldwide). These ulcers are very painful, often associated with infection, and are very difficult to heal. Gangrene leading to amputation of the fingers occurs in severe cases. In 2002, RAPIDS-1 (RAndomised Placebo-controlled Investigation of Digital ulcers in Scleroderma), Co.’s first study with BoSentan in patients with digital ulcers, showed promising results: Bosentan prevented the occurrence of new DUs in patients with scleroderma. The treatment resulted in significant improvement in hand functionality (e.g. grip, hygiene, dressing, grooming). Bosentan was safe and well tolerated. In 2003, the design for a phase III study RAPIDS-2 was discussed with the FDA and EMEA. This study examines the effects of BoSentan on the prevention and healing of digital ulcers in patients with active digital ulcers. The study started in the winter and results are expected in late 2005. |
| UPDATE | 03.04 |
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